Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Jan. 27, 2026. Claims 1-5, 9-10, 12, 14-17, 21-22 and 24-27 are pending. Claims 9-10, 15-17, 21 and 27 are withdrawn. Claims 1-5, 12-14, 22 and 24-26 are currently examined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(Previous Rejection – Maintained) Claims 1, 3-5 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shim et al. (ACS Nano, 2013, 7: 5955–5964).
Applicants argue that, in response to the rejection, claim 1 is amended to recite that “the determining comprises tracking the movement of the first labeling agent and the second labeling agent across multiple frames while the first and second labeled molecules are flowing through a microfluidic channel”, and that Shim does not teach or suggest this limitation. Applicants argue that Shim encapsulates biomolecular complexes in stationary femtodroplets that are “trapped” and “stored” in compartments for detection. Applicants argue that the droplets in Shim are stationary during detection, and that, in contrast, the claimed invention is a dynamic tracking approach where the position of the labeling agents is monitored as they move through the channel, which is fundamentally distinct from Shim’s static measurement of accumulated fluorescent in trapped, stationary droplets.
Applicants’ arguments are not persuasive. Shim shows the entire process flow in Fig. 1b, and teaches that trapping the femtodroplets in this way allows the activity of specific enzymes to be monitored continuously inside thousands of droplets simultaneously (Figure 2b), that an embedded microfluidic valve is used to flush stored droplets out of the traps and reload freshly generated femtodroplets by application and release of external pressure (about 50 psi, Supporting Movie 3), and that this process takes only about 10 s due to the extremely high frequency of droplet generation and is therefore not rate-limiting for assay repetition. See para bridging pages 5956-5957. These teachings indicate that the detection process is in flowing condition since the freshly generated droplets would flush out the “stored” and “trapped” ones. In this way, “movement” of samples are still tracked. By reciting “determining, under flow conditions” the claims do not exclude that some portions of the sample can be temporarily “stored” and “trapped” only to be “flushed out” shortly.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
(Previous Rejection – Maintained) Claims 2, 14, 22 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Shim et al. (ACS Nano, 2013, 7: 5955–5964), as applied in the 102 rejection above.
(Previous Rejection – Maintained) Claims 1-5, 12, 14, 22 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Shim et al. (ACS Nano, 2013, 7: 5955–5964), as applied in the 102 rejection above, in view of Farka et al. (Angew. Chem. Int. Ed. 2020, 59, 10746–10773. First published: 23 December 2019; submitted in IDS filed on Nov. 15, 2023). This rejection addresses the elected species of (1) a biomarker for an infectious disease for the first molecule.
Applicants argue that Shim does not disclose or suggest the amended limitations of claim 1 requiring “tracking the movement of said first labeling agent and said second labeling agent across multiple sequential frames while said labeled molecules are flowing through a microfluidic channel.” Applicants argue that Farka does not cure the deficiencies of Shim.
Applicants’ arguments are not persuasive for the same reasons explained in the Examiner’s response to Applicants’ arguments in the 102 rejection.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, on (571) 270-3497, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/
Primary Examiner, Art Unit 1671
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